CENTAUR PHARMS PVT FDA Approval ANDA 213592

ANDA 213592

CENTAUR PHARMS PVT

FDA Drug Application

Application #213592

Application Sponsors

ANDA 213592CENTAUR PHARMS PVT

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL6.25MG0ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
002TABLET, EXTENDED RELEASE;ORAL12.5MG0ZOLPIDEM TARTRATEZOLPIDEM TARTRATE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-04STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

CENTAUR PHARMS PVT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213592
            [companyName] => CENTAUR PHARMS PVT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"6.25MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"12.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-04
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.